MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED IMMULITE 2000 3GALLERGY SPECIFIC IGE

Model Number	IMMULITE 2000 3GALLERGY SPECIFIC IGE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A siemens headquarters support center (hsc) specialist reviewed the kit release data for the latest lot (kit lot 602) available for immulite 2000 3gallergy specific ige results for rat allergen (e87), which showed that the allergen is performing as expected.The hsc specialist concluded that the potential cause of the discordant results could be due to the sample specific issue.The device is performing as expected.No further evaluation of device is required.Mdr 2432235-2018-00207 has been filed for the same event for allergen e73 which has different 510(k) # of k013134.
Event or Problem Description
Discordant, false negative 3gallergy specific ige result for rat allergen (e87) (510 (k) # k021206) was obtained on one patient sample on an immulite 2000 xpi instrument, while using an unknown kit lot.The sample was also tested negative for rat epithelium allergen (e73) (510 (k) # k013134).The sample was repeated on an alternate platform for allergens e87 and e73, resulting positive.It is unknown which results were reported to the physician(s).There are no reports of patient intervention or adverse health consequences due to the discordant 3gallergy specific ige results.
Event or Problem Description
Discordant, false negative 3gallergy specific ige result for rat allergen (e87) (510 (k) # k021206) was obtained on one patient sample on an immulite 2000 xpi instrument, while using kit lot 209.
Additional Manufacturer Narrative
The initial mdr 2432235-2018-00206 was filed on 22-may-2018.Additional information (04-jun-2018): the kit lot used to test the patient sample in question for 3gallergy specific ige, rat allergen (e87) was lot 209.Upon further review of data, siemens determined that allergens from the same genus are expected to cross-react as in the case of rattus rattus (black rats) and rattus norvegicus (brown rats).Additionally, kit lot for allergen e87 expired on 31-mar-2018 and the event occurred on (b)(6) 2018.The customer used an expired kit lot to test allergen e87.Mdr 2432235-2018-00207_s1 has been filed for the same event for allergen e73 which has different 510(k) # of k013134.

• Brand Name: IMMULITE 2000 3GALLERGY SPECIFIC IGE
• Common Device Name: IMMULITE 2000 3GALLERGY SPECIFIC IGE
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS, LIMITED; glyn rhonwy; llanberis; gwynedd, LL55 4EL; UK LL55 4EL
• MDR Report Key: 7533657
• Report Number: 2432235-2018-00206
• Device Sequence Number: 16188966
• Product Code: DHB
• UDI-Device Identifier: 00630414996554
• UDI-Public: 00630414996554
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K021206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: IMMULITE 2000 3GALLERGY SPECIFIC IGE
• Device Catalogue Number: L2KUN6
• Device Lot Number: 209
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2018
• Supplement Date Received by Manufacturer: 06/04/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1